Non-small Cell Lung CancerPhase 2NSCLCNCT02147990
Multicenter Study of Rociletinib Administered to Patients With Previously Treated Mutant EGFR Non-small Cell Lung Cancer
A Phase 2 study testing Rociletinib in people with Non-small Cell Lung Cancer, run by Clovis Oncology, Inc. at 91 sites in 12 countries.
Trial summary
The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Rociletinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 91 sitesin 12 countries
- Study dates
- 16 Jun 2014to 27 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC
- Documented evidence of a tumor with 1 or more EGFR mutations excluding exon 20 insertion
- Disease progression confirmed by radiologic assessment while receiving treatment with the first single agent EGFR-TKI
- EGFR TKI treatment discontinued less than or equal to 30 days prior to planned initiation of rociletinib
- The washout period for an EGFR inhibitor is a minimum of 3 days
- No intervening treatment between cessation of single agent EGFR TKI and planned initiation of rociletinib
Show all 15Show fewer
- Previous treatment with less than or equal to 1 prior chemotherapy (excluding prior neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent)
- Any toxicity related to prior EGFR inhibitor treatment must have resolved to Grade 1 or less
- Central laboratory confirmation of the presence of the T790M mutation in tumor tissue in Cohort A and the presence or absence of the T790M mutation in tumor tissue in Cohort B. Centrally indeterminate, unknown or invalid specimens are not acceptable. Biopsy material obtained from either primary or metastatic tumor tissue and sent to the central laboratory must be within 60 prior to dosing study drug but following disease progression on the first EGFR TKI
- Measurable disease according to RECIST Version 1.1
- Life expectancy of at least 3 months
- ECOG performance status of 0 to 1
- Minimum Age 18 years (in certain territories, the minimum age requirement may be higher eg age 20 years in Japan and Taiwan)
- Adequate hematological and biological function, confirmed by defined laboratory values
- Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study specific evaluation
Who cannot join
- Documented evidence of an exon 20 insertion activating mutation in the EGFR gene
- Active second malignancy i.e. patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment
- Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enrol in the trial provided all chemotherapy was completed greater than 6 months prior and/or bone marrow transplant greater than 2 years prior
- Known pre-existing interstitial lung disease
- Cohort A only: Patients with leptomeningeal carcinomatosis are excluded. Other central nervous system (CNS) metastases are only permitted if treated, asymptomatic, and stable (not requiring steroid for at least 4 weeks prior to the start of study treatment). Cohort B only: Patients with CNS metastases or leptomeningeal carcinomatosis are excluded.
- Treatment with prohibited medications less than or equal to 14 days prior to treatment with rociletinib
Show all 19Show fewer
- Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication before starting rociletinib
- Prior treatment with rociletinib, or other drugs that target T790M positive mutant EGFR with sparing of wild type EGFR
- Any of the following cardiac abnormalities or history
- Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTCF) greater than 450 msec
- Inability to measure QT interval on ECG
- Personal or family history of long QT syndrome
- Implantable pacemaker or implantable cardioverter defibrillator
- Resting bradycardia less than 55 beats/min
- Non-study related surgical procedures less than or equal to 7 days prior to administration of rociletinib. In all cases, the patient must be sufficiently recovered and stable before treatment administration
- Females who are pregnant or breastfeeding
- Refusal to use adequate contraception for fertile patients (females and males) while on treatment and for 12 weeks after the last dose of rociletinib
- Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study
- Any other reason the investigator considers the patient should not participate in the study
Trial locations and contacts
91 sites in 12 countries.
91 sites in 12 countries
United States41 sites
UCLA Medical Center
Alhambra, California, 91801
Texas Oncology P.A.
Amarillo, Texas, 79106
USO - Texas Oncology P.A.
Arlington, Texas, 76014
Texas Oncology-Austin Central
Austin, Texas, 78705
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Texas Oncology-Beaumont
Beaumont, Texas, 77702
Texas Oncology P.A.
Bedford, Texas, 76022
Beth Israel Comprehensive Cancer Center
Boston, Massachusetts, 02215
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
University of Illinois Chicago
Chicago, Illinois, 60612
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Texas Oncology P.A.
Dallas, Texas, 75246
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Texas Oncology P.A.
Flower Mound, Texas, 75028
Saint Jude Heritage Healthcare
Fullerton, California, 92835
Saint Mary's Regional Cancer Center
Grand Junction, Colorado, 81501-6132
The Methodist Hospital
Houston, Texas, 77030
University of California San Diego Moores Cancer Center
La Jolla, California, 92093
New York Oncology Hematology, PC
Latham, New York, 12110-2188
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80218
Advanced Medical Specialties
Miami, Florida, 33176
Minnesota Oncology Hematology, P.A
Minneapolis, Minnesota, 55404
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Yale University School of Medicine
New Haven, Connecticut, 32135
Illinois Cancer Specialists
Niles, Illinois, 60714
Northridge Hospital Medical Center
Northridge, California, 91328
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Texas Oncology - Plano East
Plano, Texas, 75075-7787
Cancer Care Associates
Redondo Beach, California, 90277
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
University of California Davis Medical Center
Sacramento, California, 95817
University of California San Francisco
San Francisco, California, 94115
Coastal Integrative Cancer Care
San Luis Obispo, California, 93401
Washington University School of Medicine
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10461
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98686
Cleveland Clinic Florida
Weston, Florida, 33331
Yakima Valley Memorial Hospital, North Star Lodge
Yakima, Washington, 98902
South Korea10 sites
Dong-A University Hospital
Busan
Chungbuk National University Hospital
Chungju, North Chungcheong
National Cancer Center
Goyang-si, Gyeonggi-do
Gachon University Gil Medical Center
Incheon, Gyeonggi-do, 405-760
Inha University Hospital
Incheon, 400-711
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul Saint Mary's Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Germany9 sites
Evangelische Lungenklinik Berlin
Berlin, 13125
Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III
Bonn, North Rhine-Westphalia, 53127
Universitätsklinikum Köln
Cologne, North Rhine-Westphalia, 50937
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45122
Goethe-Universität Frankfurt am Main
Frankfurt am Main, Hesse, 60590
Asklepios Fachkliniken München-Gauting
Gauting, Bavaria, 82131
LungenClinic Großhansdorf GmbH
Großhansdorf, Schleswig-Holstein, 22927
Klinikum Innenstadt LMU
München, Bavaria, 80336
Pius Hospital Oldenburg
Oldenburg, Lower Saxony, 26121
France7 sites
Centre Hospitalier Regional Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz
Besançon, Franche-comte, 25030 cedex
Centre Hospitalier Universitaire Côte de Nacre
Caen
Centre Hospitalier Universitaire Hôpital Nord
Marseille, 13915
Hôpital Tenon
Paris, Île-de-France Region, 75020
Centre Hospitalier Lyon Sud
Pierre Bénité Cedex, Auvergne-Rhône-Alpes, 69495
Institut de Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, Pays de la Loire Region
Institut Gustave Roussy
Villejuif, Île-de-France Region, 94805
Spain5 sites
Hospital Universitari Germans Trias i Pujol
Badalona
Hospital Vall d´Hebrón
Barcelona, 08035
Hospital Universitario Quirón Dexeus
Barcelona
Hospital Universitario La Paz
Madrid
Hospital Universitario Virgen del Rocio
Seville, Sevilla, 41013
Taiwan5 sites
China Medical University Hospital
Taichung, 40447
Taichung Veterans General Hospital
Taichung, 40705
Taipei Veterans General Hospital
Taipei, Taipei CITY, 11217
National Taiwan University Hospital
Taipei, 100
Chang Gung Memorial Hospital Linkou
Taoyuan, Tao-Yuan, 33305
United Kingdom5 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 0QQ
Guy's and Saint Thomas NHS Foundation Trust
London, Greater London, SE1 9RT
Royal Marsden Hospital
London, Greater London, SW3 6JJ
University College Hospital
London, NW1 2PQ
Royal Marsden NHS Trust
Sutton, Surrey, SM2 5PT
Australia4 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Icon Cancer Centre
South Brisbane, New South Wales, 4101
Royal North Shore Hospital
Sydney, New South Wales, 2065
Westmead Hospital
Westmead, New South Wales, 2145
Netherlands2 sites
Antoni van Leeuwenhoek Hospital
Amsterdam, North Holland, 1066 CX
Vrije Universiteit Medisch Centrum
Amsterdam, 1081 HV
Switzerland1 site
Centre Hospitalier Universitaire Vaudoise
Lausanne, Canton of Vaud, 1011
About this study
Official title: TIGER-2: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-directed TKI in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC)
The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them.
Read the detailed description
This is a Phase 2, single arm, open-label, dual cohort, multicenter study evaluating the safety and efficacy of rociletinib administered orally to patients with previously treated mutant EGFR NSCLC.
Patients will be enrolled into 2 cohorts. Cohort A will enroll approximately 125 eligible patients who are centrally confirmed T790M-positive. Cohort B will be a continuation of the study and will enroll up to approximately 100 eligible patients who will be either centrally confirmed T790M-positive or T790M-negative.
All patients (for Cohort A and B) should have experienced disease progression while on treatment with the first single-agent EGFR-directed TKI (EGFR-TKI) for advanced/metastatic NSCLC. One line of chemotherapy prior to the EGFR-TKI treatment is permissible.
The study (Cohorts A and B) will consist of a screening phase to establish study eligibility and document baseline measurements, an open-label treatment phase, in which the patient will receive rociletinib to ascertain safety and efficacy until disease progression as defined by RECIST Version 1.1, clinical tumor progression, or unacceptable toxicity as assessed by the investigator. For patients with clinical progression, radiographic assessment should be performed to document evidence of radiographic progression.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Rociletinib
- Keywords
- cancer, metastatic, locally advanced, lung, non-small cell lung cancer, NSCLC, epidermal growth factor receptor, EGFR, T790M, CO-1686, unresectable, recurrent, EGFR-directed therapy, irreversible EGFR inhibitor, TIGER, Rociletinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasms, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RociletinibDrug
Also called CO-1686
Rociletinib will be administered to patients orally
| Study group | Role | What they receive |
|---|---|---|
| Rociletinib Mono-Therapy, T790M +ve (625mg BID) | Experimental | Starting dose of 625mg rociletinib, taken orally twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days. Receives: Drug: Rociletinib |
| Rociletinib Mono-Therapy, T790M +ve (500mg BID) | Experimental | Starting dose of 500mg rociletinib, taken orally twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days. Receives: Drug: Rociletinib |
| Rociletinib Mono-Therapy, T790M -ve (500mg BID) | Experimental | Starting dose of 500mg rociletinib, taken twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days. Receives: Drug: Rociletinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) According to RECIST Version 1.1 as Determined by Investigator Assessment
ORR is defined as the percentage of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Measured: Cycle 1 Day 1 to End of Treatment, up to approximately 57 months.
Secondary outcomes (18)
Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment
DOR in patients with a T790M mutation (determined by central lab) with confirmed response per investigator. The DOR for complete response (CR) and partial response (PR) was measured from the date that any of these best responses is first recorded until the first date that progressive disease (PD) is objectively documented. For patients who continue treatment post-progression, the first date of progression was used for the analysis.
Measured: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 54 months
Disease Control Rate (DCR) by RECIST v1.1 as Determined by Investigator Assessment
DCR is defined as the percentage of patients who have achieved CR, PR, and SD lasting at least 12 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started.
Measured: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 57 months
Progression-free Survival (PFS) in T790M Positive Patients by RECIST v1.1 as Determined by Investigator Assessment
PFS was calculated as 1+ the number of days from the first dose of study drug to documented radiographic progression or death due to any cause, whichever occurs first. Patients without a documented event of radiographic progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment) or date of first dose of study drug if no tumor assessments were performed. For patients who continued treatment post-progression, the first date of progression was used for the analysis of PFS. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Measured: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 57 months
Overall Survival (OS) Determined by Investigator Assessment
OS was calculated as 1+ the number of days from the first dose of study drug to death due to any cause. Patients without a documented date of death will be censored on the date the patient was last known to be alive.
Measured: Cycle 1 Day 1 to date of death, assessed up to 57 months
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Scale
EORTC QLC-C30 is a 30-item questionnaire to assess the quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); two used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in Dermatology Life Quality Index (DLQI)
Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Alopecia Scale
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Coughing Scale
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dysphagia Scale
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dyspnoea Scale
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Haemoptysis Scale
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Arm or Shoulder Scale
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Chest Scale
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Medicine for Pain Scale
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Other Parts Scale
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Peripheral Neuropathy Scale
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Sore Mouth Scale
EORTC QLQ-LC13 is the lung cancer module of EORTC QLQ-C30 and includes questions specific to the disease associated symptoms (dyspnea, cough, hemoptysis, and site specific pain), treatment-related symptoms (sore mouth, dysphagia, neuropathy and alopecia), and analgesic use of lung cancer patients. The scale was transformed to a range of 0 to 100 using standard EORTC algorithm. Higher score indicates worse symptoms.
Measured: Baseline (Day 0), Months 5, 10 and EOT
Population PK (POPPK) and Exposure-Response (ER) Analysis of Rociletinib
Sparse blood sampling for POPPK and ER analyses in all patients treated with rociletinib.
Measured: Every 4 weeks for approximately 6 months (Day 1 of Cycles 2 to 7 inclusive)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study start16 Jun 2014
- Primary completion30 Jul 2019
- Study completion27 Aug 2019
Why it stopped: Sponsor discontinued development of CO-1686 for NSCLC.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clovis Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147990
- Sponsor's protocol ID
- CO-1686-019 (TIGER-2)
- Acronym
- NSCLC
- Status last verified
- Jul 2020
- First submitted
- 13 May 2014
- Last updated
- 12 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIGER-2: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-directed TKI in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02147990
- Acronym / sponsor ID
- NSCLC / CO-1686-019 (TIGER-2)
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- cancer, metastatic, locally advanced, lung, non-small cell lung cancer, NSCLC, epidermal growth factor receptor, EGFR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor discontinued development of CO-1686 for NSCLC.
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Clovis Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them.
Detailed description
This is a Phase 2, single arm, open-label, dual cohort, multicenter study evaluating the safety and efficacy of rociletinib administered orally to patients with previously treated mutant EGFR NSCLC.
Patients will be enrolled into 2 cohorts. Cohort A will enroll approximately 125 eligible patients who are centrally confirmed T790M-positive. Cohort B will be a continuation of the study and will enroll up to approximately 100 eligible patients who will be either centrally confirmed T790M-positive or T790M-negative.
All patients (for Cohort A and B) should have experienced disease progression while on treatment with the first single-agent EGFR-directed TKI (EGFR-TKI) for advanced/metastatic NSCLC. One line of chemotherapy prior to the EGFR-TKI treatment is permissible.
The study (Cohorts A and B) will consist of a screening phase to establish study eligibility and document baseline measurements, an open-label treatment phase, in which the patient will receive rociletinib to ascertain safety and efficacy until disease progression as defined by RECIST Version 1.1, clinical tumor progression, or unacceptable toxicity as assessed by the investigator. For patients with clinical progression, radiographic assessment should be performed to document evidence of radiographic progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rociletinib Mono-Therapy, T790M +ve (625mg BID) | Experimental | Drug: RociletinibStarting dose of 625mg rociletinib, taken orally twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days. |
| Rociletinib Mono-Therapy, T790M +ve (500mg BID) | Experimental | Drug: RociletinibStarting dose of 500mg rociletinib, taken orally twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days. |
| Rociletinib Mono-Therapy, T790M -ve (500mg BID) | Experimental | Drug: RociletinibStarting dose of 500mg rociletinib, taken twice daily, with 8 oz (240 mL) of water and with a meal or within 30 minutes after a meal. Tablets should be swallowed whole. Treatment with rociletinib is continuous and each cycle will comprise of 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically confirmed metastatic or unresectable locally advanced NSCLC
- Documented evidence of a tumor with 1 or more EGFR mutations excluding exon 20 insertion
- Disease progression confirmed by radiologic assessment while receiving treatment with the first single agent EGFR-TKI
- EGFR TKI treatment discontinued less than or equal to 30 days prior to planned initiation of rociletinib
- The washout period for an EGFR inhibitor is a minimum of 3 days
Key exclusion criteria (19 listed)
- Documented evidence of an exon 20 insertion activating mutation in the EGFR gene
- Active second malignancy i.e. patient known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment
- Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enrol in the trial provided all chemotherapy was completed greater than 6 months prior and/or bone marrow transplant greater than 2 years prior
- Known pre-existing interstitial lung disease
- Cohort A only: Patients with leptomeningeal carcinomatosis are excluded. Other central nervous system (CNS) metastases are only permitted if treated, asymptomatic, and stable (not requiring steroid for at least 4 weeks prior to the start of study treatment). Cohort B only: Patients with CNS metastases or leptomeningeal carcinomatosis are excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RociletinibAlso: CO-1686Rociletinib will be administered to patients orally | Drug | Rociletinib Mono-Therapy, T790M +ve (500mg BID), Rociletinib Mono-Therapy, T790M +ve (625mg BID), Rociletinib Mono-Therapy, T790M -ve (500mg BID) |
Primary outcome
Objective Response Rate (ORR) According to RECIST Version 1.1 as Determined by Investigator Assessment
Time frame: Cycle 1 Day 1 to End of Treatment, up to approximately 57 months.
ORR is defined as the percentage of patients with a best overall confirmed response of partial response (PR) or complete response (CR) recorded from the start of the treatment until disease progression. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
18 secondary outcomes
Duration of Response (DOR) in T790M Positive Patients According to RECIST Version 1.1 as Determined by Investigator Assessment
Time frame: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 54 months
Disease Control Rate (DCR) by RECIST v1.1 as Determined by Investigator Assessment
Time frame: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 57 months
Progression-free Survival (PFS) in T790M Positive Patients by RECIST v1.1 as Determined by Investigator Assessment
Time frame: From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 57 months
Overall Survival (OS) Determined by Investigator Assessment
Time frame: Cycle 1 Day 1 to date of death, assessed up to 57 months
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Quality of Life Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in Dermatology Life Quality Index (DLQI)
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Alopecia Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Coughing Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dysphagia Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Dyspnoea Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Haemoptysis Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Arm or Shoulder Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Chest Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Medicine for Pain Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Pain in Other Parts Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Peripheral Neuropathy Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Change From Baseline to Cycles 5, 10 and End of Treatment (EOT) in EORTC QLQ-LC-13 Sore Mouth Scale
Time frame: Baseline (Day 0), Months 5, 10 and EOT
Population PK (POPPK) and Exposure-Response (ER) Analysis of Rociletinib
Time frame: Every 4 weeks for approximately 6 months (Day 1 of Cycles 2 to 7 inclusive)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
91 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rociletinib in people with Non-small Cell Lung Cancer, run by Clovis Oncology, Inc. at 91 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 91 sites in United States, South Korea, Germany, France, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) According to RECIST Version 1.1 as Determined by Investigator Assessment (time frame: Cycle 1 Day 1 to End of Treatment, up to approximately 57 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.